G-6-PDH Deficient and Normal Control (2019-03-26)

Starting date:

March 26, 2019

Posting date:

April 9, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69548

Last updated: 2019-05-17

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  Reason
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  Affected products

Affected Products

G-6-PDH Deficient and Normal Control

Reason

Randox is conducting a Field Safety Corrective Action for G6PDH Deficient and Normal Controls for the lots specified in the Field Safety Notice . The target values and ranges are incorrect and are re-assigned. In addition customers are reminded to follow the assay protocol for G6PDH in the Instructions for Use (PD410) and to use the quoted calibration factor to ensure accuracy of results.

Affected products